MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3501670
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported by a physician's office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue.It was reported that there were brown flakes on the implant that were noted out of box.Per the customer, the implant did not come into contact with any patient.No patient consequence was reported.The customer requested that no further contact be initiated for follow up attempts.Therefore, no additional information is available.
Additional Manufacturer Narrative
On 10/27/2017, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).
Additional Manufacturer Narrative
Device evaluation summary: it was reported by a physician's office that a mentor smooth round moderate profile saline implant (catalog # 3501670, serial # (b)(4)) had brown flakes on the implant out of the box.Upon receipt at mentor, it was noted that the device contained no fluid and could not be weighed.No foreign material was observed within the device or on the shell surface.The device appeared clean and intact.No packaging was returned.No anomalies were discovered.The device history record (dhr) of lot number 7483717 was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint could not be confirmed.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6975001
• Report Number: 1645337-2017-00122
• Device Sequence Number: 1209940
• Product Code: FWM
• UDI-Device Identifier: 00081317001287
• UDI-Public: (01)00081317001287(11)170717(17)210716
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: 3501670
• Device Catalogue Number: 3501670
• Device Lot Number: 7483717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 10/09/2017; 10/09/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/01/2017; 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1